Tracheal IntubationNCT07165314
Assessment of Provider Position for Prehospital Tracheal Intubation
A study testing Free positioning and Sitting cross-legged ("Lotus" position) in people with Tracheal Intubation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Endotracheal intubation may be needed in critically ill patients in the prehospital setting, where difficult conditions may be encountered. The patient may be lying on the ground, thus complicating direct laryngoscopy as the operator's visual axis cannot be properly aligned with the patient's oral-pharyngeal-tracheal… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Free positioning and Sitting cross-legged ("Lotus" position)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All resident doctors with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM) - Performed less than 10 ETIs prior to take part in the research
Who cannot join
- More than 6 years of post-graduate experience
- Performed more than 10 ETIs prior to take part in the research
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1205
About this study
Official title: Assessment of Provider Position for Prehospital Tracheal Intubation Using Direct Laryngoscopy: Randomized Controlled Trial
Endotracheal intubation may be needed in critically ill patients in the prehospital setting, where difficult conditions may be encountered. The patient may be lying on the ground, thus complicating direct laryngoscopy as the operator's visual axis cannot be properly aligned with the patient's oral-pharyngeal-tracheal axis. The posture sitting cross-legged ("Lotus" position) at the head of the patient may allow an easier alignment of the visual axes due to a lower operator's head position and more stability. We compared the impact of the "Lotus" position with free positioning of the operator for direct laryngoscopy on intubation first pass success rate among novice operators.
- Conditions
- Tracheal Intubation
- Being tested
- Free positioning, Sitting cross-legged ("Lotus" position)
- Keywords
- advanced airway management, laryngoscopy, sitting position, prehospital, manikin, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free positioningProcedure or surgery
Participants are not given instructions on how to position for intubation using direct laryngoscopy.
Sitting cross-legged ("Lotus" position)Procedure or surgery
Participants are requested to sit cross-legged for intubation using direct laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Free positioning | Active comparator | Not described Receives: Procedure: Free positioning |
| Sitting cross-legged ("Lotus" position) | Experimental | Not described Receives: Procedure: Sitting cross-legged ("Lotus" position) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success rate
In percentage, defined as achieving successful ETI on the initial attempt. An ETI attempt was counted since the laryngoscope blade was inserted at the dental arch, regardless of whether tracheal tube placement was attempted or not. ETI was considered successful when adequate ventilation was confirmed by chest elevation. The number of intubation attempts were limited to three, with a time limit of 60 seconds allowed per attempt.
Measured: Periprocedural
Secondary outcomes (6)
Time to Intubation
Time in seconds from blade insertion at the dental arch to successful ventilation. A maximum of 60 seconds was allowed per ETI attempt.
Measured: Periprocedural
Time to Intubation for the first intubation attempt alone
Time in seconds from blade insertion at the dental arch to adequate ventilation, ruling out first-attempt failures. A maximum of 60 seconds was allowed per ETI attempt.
Measured: Periprocedural
Number of intubations attempts
An ETI attempt was counted since the laryngoscope blade was inserted at the dental arch, regardless of whether tracheal tube placement was attempted or not. ETI was considered successful when adequate ventilation was confirmed by chest elevation. The number of intubation attempts were limited to three, with a time limit of 60 seconds allowed per attempt.
Measured: Periprocedural
Cormack and Lehane (CL) score
For each attempt, the view of the larynx was assessed by the participant using the Cormack-Lehane score.
Measured: Periprocedural
Percentage Of Glottis Opening (POGO) score
For each attempt, the percentage of glottis opening was assessed by the participant, using the POGO score.
Measured: Periprocedural
Subjective assessments
Perceived difficulty was appraised using a 5-point Likert scale ranging from "Totally Agree" to "Totally Disagree".
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cédric Cibotto, University Hospital, Geneva
- Investigators
- Laurent SUPPAN, PD Dr, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165314
- Sponsor's protocol ID
- Req-2025-01129
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Provider Position for Prehospital Tracheal Intubation Using Direct Laryngoscopy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07165314
- Acronym / sponsor ID
- Req-2025-01129
- Conditions
- Tracheal Intubation
- Keywords
- advanced airway management, laryngoscopy, sitting position, prehospital, manikin, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endotracheal intubation may be needed in critically ill patients in the prehospital setting, where difficult conditions may be encountered. The patient may be lying on the ground, thus complicating direct laryngoscopy as the operator's visual axis cannot be properly aligned with the patient's oral-pharyngeal-tracheal axis. The posture sitting cross-legged ("Lotus" position) at the head of the patient may allow an easier alignment of the visual axes due to a lower operator's head position and more stability. We compared the impact of the "Lotus" position with free positioning of the operator for direct laryngoscopy on intubation first pass success rate among novice operators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free positioning | Active comparator | Procedure: Free positioning |
| Sitting cross-legged ("Lotus" position) | Experimental | Procedure: Sitting cross-legged ("Lotus" position) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All resident doctors with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM) - Performed less than 10 ETIs prior to take part in the research
Key exclusion criteria (2 listed)
- More than 6 years of post-graduate experience
- Performed more than 10 ETIs prior to take part in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free positioningParticipants are not given instructions on how to position for intubation using direct laryngoscopy. | Procedure or surgery | Free positioning |
| Sitting cross-legged ("Lotus" position)Participants are requested to sit cross-legged for intubation using direct laryngoscopy. | Procedure or surgery | Sitting cross-legged ("Lotus" position) |
Primary outcome
First Pass Success rate
Time frame: Periprocedural
In percentage, defined as achieving successful ETI on the initial attempt. An ETI attempt was counted since the laryngoscope blade was inserted at the dental arch, regardless of whether tracheal tube placement was attempted or not. ETI was considered successful when adequate ventilation was confirmed by chest elevation. The number of intubation attempts were limited to three, with a time limit of 60 seconds allowed per attempt.
6 secondary outcomes
Time to Intubation
Time frame: Periprocedural
Time to Intubation for the first intubation attempt alone
Time frame: Periprocedural
Number of intubations attempts
Time frame: Periprocedural
Cormack and Lehane (CL) score
Time frame: Periprocedural
Percentage Of Glottis Opening (POGO) score
Time frame: Periprocedural
Subjective assessments
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent SUPPAN, PD Dr study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free positioning and Sitting cross-legged ("Lotus" position) in people with Tracheal Intubation, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Pass Success rate (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.